Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02862301
Other study ID # API/2015/64
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date September 2020

Study information

Verified date November 2019
Source Centre Hospitalier Universitaire de Besancon
Contact Matthieu Béreau, MD
Email mbereau@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to compare the enzymatic activity of HATs and HDACs in peripheral blood mononuclear cell (PBMC) of patients with a clinically isolated syndrome (CIS group) and healthy controls (control group).


Description:

Multiple sclerosis (MS) is an autoimmune inflammatory demyelinating disease of the central nervous system (CNS). Clinically isolated syndrome (CIS) is often a sign of multiple sclerosis and the term refers to the first episode of neurologic symptoms experienced by a patient. Possible presentations of CIS include optic neuritis, a brain stem and/or cerebellar syndrome, a spinal cord syndrome, or occasionally cerebral hemispheric dysfunction. An accurate diagnosis at this time is important because people with a high risk of developing MS are encouraged to begin treatment in order to delay or prevent a second neurologic episode and, therefore, the onset of MS.

The innate and adaptative immune systems play an important role in pathophysiology of MS, acting in interaction with environmental, genetic, and epigenetic factors.

Epigenetic modifications, such as DNA methylation and histone modification, alter DNA accessibility and chromatin structure, thereby regulating patterns of gene expression. These processes are crucial to normal development and differentiation of distinct cell lineages in the adult organism. Histone acetylation, through the family of histone acetyl transferase (HAT), is most consistently associated with promoting transcription. Deacetylation of histones correlates with CpG methylation and the inactive state of chromatin. There are 4 classes of histone deacetylase enzymes (HDACs), with members capable of deacetylation of histones and/or other protein targets. Acetylation homeostasis is a key regulator of both immune cell activation. Of note, potent histone deacetylase inhibitors (HDACi) endowed with antiinflammatory and neuroprotective properties have been identified. Efficacy of HDACi in experimental models of MS has been reported consistently. This study could provide information on the mechanisms involved.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date September 2020
Est. primary completion date June 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Clinically isolated syndrome within the last 6 weeks (CIS group)

- Healthy volunteer, free of any inflammatory disease (control group)

- Patient able to understand the reason of the study

- Signed informed consent

Exclusion Criteria:

- Pregnancy

- Systemic corticosteroid therapy (>1mg/kg)

- Immunosuppressive/immunomodulatory therapy (prior or ongoing) (CIS group)

- Patient with ongoing infection (Control group)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
blood sample


Locations

Country Name City State
France University Hospital Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary HDAC/ HAT enzymatic activity (ratio) day of inclusion
See also
  Status Clinical Trial Phase
Recruiting NCT05982925 - Longitudinal Cortical Demyelination in Multiple Sclerosis and Related Disorders
Recruiting NCT04386018 - A Registered Cohort Study of Inflammatory Demyelination Disease
Recruiting NCT05792176 - Ukulele Playing to Improve Cognition in People With Multiple Sclerosis: A Feasibility Study N/A
Completed NCT04837651 - Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab
Recruiting NCT04786821 - Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis N/A
Completed NCT01056471 - Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis Phase 1/Phase 2
Not yet recruiting NCT03297177 - Autologous Stem/Stromal Cells in Neurological Disorders and Disease N/A
Recruiting NCT04762342 - Power Training in Older Multiple Sclerosis Patients N/A
Completed NCT00304291 - A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease) Phase 4
Recruiting NCT04539002 - Aerobic Exercise for Remyelination in Multiple Sclerosis Phase 1/Phase 2
Recruiting NCT05834855 - Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS Phase 3